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510(k) K980165

INFUTEST 2000 INFUSION DEVICE ANALYZER by Datrend Systems, Inc. — Product Code MRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1998
Date Received
January 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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